Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy
Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy
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DOI：
10.1212/wnl.0000000000001334
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发表时间：
2015-03-10
期刊：
影响因子：
9.9
通讯作者：
Fisher, Robert
中科院分区：
文献类型：
--
作者：
Salanova, Vicenta;Witt, Thomas;Fisher, Robert
目的：报告 SANTE 试验的长期疗效和安全性结果，该试验研究丘脑前核 (ANT) 脑深部刺激治疗定位相关性癫痫。方法：这项长期随访是先前报道的 5-V 与 0-V ANT 刺激试验的延续。设备植入后 13 个月开始长期随访，并根据研究人员的判断调整刺激参数。使用每日癫痫发作日记确定癫痫发作频率。结果：1 年时癫痫发作相对于基线减少的中位百分比为 41%，5 年时为 69%。 1 年时的缓解率（癫痫发作频率减少 50% 以上）为 43%，5 年时为 68%。在 5 年的随访中，16% 的受试者至少 6 个月没有癫痫发作。没有报告意外的装置不良反应或有症状的颅内出血。利物浦癫痫严重程度量表和 31 项癫痫生活质量测量显示，1 年和 5 年较基线有统计学显着改善 (p < 0.001)。结论：ANT 深部脑刺激的长期随访显示，在治疗抵抗人群中具有持续的有效性和安全性。证据分类：这项长期随访提供了 IV 类证据，表明对于耐药部分性癫痫患者，前丘脑刺激与 5 年时癫痫发作频率降低 69% 以及与设备相关的严重不良事件发生率降低 34% 相关。
Objective: To report long-term efficacy and safety results of the SANTE trial investigating deep brain stimulation of the anterior nucleus of the thalamus (ANT) for treatment of localization-related epilepsy.Methods: This long-term follow-up is a continuation of a previously reported trial of 5-vs 0-V ANT stimulation. Long-term follow-up began 13 months after device implantation with stimulation parameters adjusted at the investigators' discretion. Seizure frequency was determined using daily seizure diaries.Results: The median percent seizure reduction from baseline at 1 year was 41%, and 69% at 5 years. The responder rate (>= 50% reduction in seizure frequency) at 1 year was 43%, and 68% at 5 years. In the 5 years of follow-up, 16% of subjects were seizure-free for at least 6 months. There were no reported unanticipated adverse device effects or symptomatic intracranial hemorrhages. The Liverpool Seizure Severity Scale and 31-item Quality of Life in Epilepsy measure showed statistically significant improvement over baseline by 1 year and at 5 years (p < 0.001).Conclusion: Long-term follow-up of ANT deep brain stimulation showed sustained efficacy and safety in a treatment-resistant population. Classification of evidence: This long-term follow-up provides Class IV evidence that for patients with drug-resistant partial epilepsy, anterior thalamic stimulation is associated with a 69% reduction in seizure frequency and a 34% serious device-related adverse event rate at 5 years.